Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics
PURPOSE: To determine bioactivity and duration of effect of intravitreal aflibercept injection (also known as vascular endothelial growth factor Trap-Eye) for neovascular age-related macular degeneration (AMD).
METHODS: In this double-masked, phase 1 study, 28 patients with lesions ≤12 disc areas, ≥50% active choroidal neovascularization (CNV), and best corrected visual acuity (BCVA) ≤20/40 were randomized 1:1 to a single intravitreal injection of aflibercept 0.15 or 4 mg. The primary end point was the change from baseline in central retinal/lesion thickness (CR/LT) at week-8. Secondary outcomes were the change from baseline BCVA, the change in CNV lesion size and area of leakage, and proportion of patients requiring repeat injection at 8 weeks.
RESULTS: Mean percent decrease in CR/LT for the 4-mg and 0.15-mg groups was, respectively, 34.2 versus 13.3 at week 4 (P=0.0065), 23.8 versus 5.9 at week 6 (P=0.0380), and 25.2% versus 11.3% at week 8 (P=0.150). The 4-mg group gained a mean of 4.5 letters in BCVA (6/14 patients gaining ≥10 letters) versus 1.1 letters in 0.15-mg group (1/14 gaining ≥10 letters) at week 8. Fewer patients needed retreatment in the 4-mg group at week 8. No serious adverse event or ocular inflammation was reported in either group.
CONCLUSIONS: Intravitreal aflibercept 4 mg had a safety profile similar to that of the very low dose 0.15 mg, and was well-tolerated. The 4-mg dose significantly reduced foveal thickening at weeks 4 and 6, significantly improved BCVA at weeks 6, and reduced the need for repeat injection after 8 weeks compared with intravitreal aflibercept 0.15 mg in neovascular AMD patients.
Aged, Aged, 80 and over, Choroidal Neovascularization, Dose-Response Relationship, Drug, Double-Blind Method, Female, Fovea Centralis, Humans, Intravitreal Injections, Macular Degeneration, Male, Middle Aged, Prospective Studies, Receptors, Vascular Endothelial Growth Factor, Recombinant Fusion Proteins, Treatment Outcome, Visual Acuity
Dong Nguyen, Quan; Campochiaro, Peter A.; Shah, Syed Mahmood; Browning, David J.; Hudson, Henry L.; Sonkin, Peter L.; Hariprasad, Seenu M.; Kaiser, Peter K.; Slakter, Jason; Haller, Julia A.; Do, Diana V.; Mieler, William; Chu, Karen; Ingerman, Avner; Vitti, Robert; Berliner, Alyson J.; Cedarbaum, Jesse; and CLEAR-IT 1 Investigators, "Evaluation of very high- and very low-dose intravitreal aflibercept in patients with neovascular age-related macular degeneration." (2012). Journal Articles: Ophthalmology. Paper 8.